Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?
|Schizophrenia Schizoaffective Disorder||Drug: divalproex sodium ER Drug: placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?|
- Improvements in cognition and psychopathology [ Time Frame: six weeks ]
|Study Start Date:||March 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Drug: divalproex sodium ER
divalproex sodium ER1000 mg
|Placebo Comparator: 2||
placebo identical in appearance to active comparator
Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients.
The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306475
|United States, Tennessee|
|Psychiatric Hospital at Vanderbilt|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Stefania Bonaccorso, M.D.||Vanderbilt University Medical Center|